GSO ISO 25539-3:2024
ISO 25539-3:2011
Gulf Standard
Current Edition
·
Approved on
25 April 2024
Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
GSO ISO 25539-3:2024 Files
English
93 Pages
Current Edition
Reference Language
92.8 BHD
GSO ISO 25539-3:2024 Scope
ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The following are within the scope of ISO 25539-3:2011:
- vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites;
- sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter.
- delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter.
- optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.
The following are outside the scope of ISO 25539-3:2011:
- temporary filters (e.g. tethered) that need to be removed after a defined period of time;
- coatings, surface modifications, and/or drugs;
- issues associated with viable tissues and non-viable biological materials;
- degradation and other time-dependent aspects of absorbable materials;
- procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023
Bahraini Standard
Personal Care and Baby Wet Wipes
BH GSO 2241:2023
GSO 2241:2023
Bahraini Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
Recently Published from Health Sector
GSO ISO 11608-7:2024
ISO 11608-7:2016
Gulf Standard
Needle-based injection systems for medical use
— Requirements and test methods
— Part 7: Accessibility for persons with visual impairment
GSO ISO/TR 24666:2024
ISO/TR 24666:2023
Gulf Standard
Sports and recreational facilities
— Probes for entrapment/entanglement on playground equipment
— Collection of data
GSO ISO 9713:2024
ISO 9713:2022
Gulf Standard
Neurosurgical implants
— Self-closing intracranial aneurysm clips
GSO ISO/TS 22690:2024
ISO/TS 22690:2021
Gulf Standard
Genomics informatics
— Reliability assessment criteria for high-throughput gene-expression data